What is NDC 68083-293?

68083-293 is the product NDC for Fluorouracil, Fluorouracil 50 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluorouracil?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluorouracil NDC 68083-293 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-293Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0293Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68083-293-01	6808302930168083029301	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-293-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Jan 5, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Fluorouracil
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210124
Marketing start: Jan 5, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 68083-293_4680580c-772c-490d-bde9-c506c961e0b8SPL ID 4680580c-772c-490d-bde9-c506c961e0b8SPL set ID ea3497db-23b9-4ace-9a6f-b54853d04a82RxCUI 239177UNII U3P01618RTUPC 0368083292010, 0368083293017
Pharmacologic class: Nucleoside Metabolic Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083029301 followed by a unit qualifier and the quantity

Package 68083-0293-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Fluorouracil is indicated for the treatment of patients with: 1.1 Adenocarcinoma of the Colon and Rectum 1.2 Adenocarcinoma of the Breast 1.3 Gastric Adenocarcinoma 1.4 Pancreatic Adenocarcinoma Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with • Adenocarcinoma of the Colon and Rectum (1.1) • Adenocarcinoma of the Breast (1.2) • Gastric Adenocarcinoma (1.3) • Pancreatic Adenocarcinoma (1.4)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-293

What is NDC 68083-293?: 68083-293 is the product NDC for Fluorouracil, Fluorouracil 50 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluorouracil.
What is the active ingredient?: Fluorouracil.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluorouracil?: 40 other product NDCs are listed under this name. See all Fluorouracil NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluorouracil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-972	23155-0972-41
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-973	23155-0973-41
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-974	23155-0974-31
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-975	23155-0975-31
Fluorouracilfluorouracil cream, 0.5%	Fluorouracil 5 mg/g	CreamTopical	Dr. Reddy's Laboratories Inc.	75907-169	75907-0169-11
Fluorouracil	Fluorouracil 2 g/40g	CreamTopical	Encube Ethicals, Inc.	21922-049	21922-0049-17
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-154	71288-0154-76
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-628	68001-0628-32
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-627	68001-0627-27
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-170	71288-0170-75

All 41 Fluorouracil NDCs

Other NDCs under ANDA 210124

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210124
Product	Strength	Form · route	Labeler	Product NDC
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-974
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-975
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-525
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-292
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Xiromed LLC	70700-188
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Xiromed LLC	70700-189